Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 739.66 million, a significant increase of 76.5% compared to RMB 419.07 million for the same period in 2023[6]. - Gross profit for the first half of 2024 was RMB 570.39 million, up from RMB 316.42 million in the same period last year, reflecting a gross margin improvement[6]. - The company reported a pre-tax loss of RMB 780.46 million for the first half of 2024, compared to a pre-tax loss of RMB 703.36 million in the same period of 2023[6]. - The company reported a net loss of RMB 780.5 million for the six months ended June 30, 2024, compared to a net loss of RMB 703.4 million for the same period in 2023[43]. - The total comprehensive loss for the period was RMB 806,453 thousand, compared to RMB 709,024 thousand in the same period of 2023[153]. - The basic loss per share for the period was calculated based on a weighted average number of shares of 537,631,657, slightly down from 539,347,672 in the previous year[178]. Assets and Liabilities - Total assets as of June 30, 2024, reached RMB 5,754.54 million, an increase from RMB 5,528.24 million as of December 31, 2023[6]. - Total liabilities as of June 30, 2024, were RMB 3,089.93 million, compared to RMB 2,090.97 million as of December 31, 2023, indicating increased leverage[6]. - Total equity decreased to RMB 2,664.61 million as of June 30, 2024, from RMB 3,437.27 million as of December 31, 2023[6]. - The debt-to-asset ratio increased to 53.7% as of June 30, 2024, compared to 37.8% as of December 31, 2023[45]. - Cash and cash equivalents decreased to RMB 673,322 thousand from RMB 726,552 thousand, indicating a reduction in liquidity[155]. Research and Development - Research and development expenses increased to RMB 806.23 million in the first half of 2024, compared to RMB 540.45 million in the same period of 2023, indicating a focus on innovation[6]. - The company has a robust pipeline with over ten drug candidates, seven of which are in clinical development targeting more than twenty indications[7]. - The company is exploring Taitasip's potential for treating other autoimmune diseases, including antiphospholipid syndrome and thrombocytopenia[14]. - The company has received breakthrough therapy designation for Taitasip in gMG from the FDA in the U.S.[13]. Clinical Trials and Approvals - Taitasip (RC18) received full NMPA approval for systemic lupus erythematosus (SLE) in China in November 2023, with successful inclusion in the national medical insurance catalog by the end of 2023[11]. - A Phase III clinical trial for Taitasip in rheumatoid arthritis (RA) yielded positive results in Q2 2023, with a BLA submitted to NMPA in August 2023 and approval expected in July 2024[12]. - The company initiated a Phase III clinical trial for generalized myasthenia gravis (gMG) in China in H1 2023, with primary endpoints expected to be met by August 2024[13]. - The global Phase III trial for SLE is ongoing, addressing significant unmet medical needs[11]. Market Presence and Products - RemeGen has commercialized two products, RC18 (brand name: Tai'ai®) and RC48 (brand name: Aidiqi®), which are undergoing clinical trials in China and the United States[7]. - The company aims to become a leading player in the global biopharmaceutical industry by addressing unmet medical needs in autoimmune, oncology, and ophthalmology diseases[7]. - The company is actively expanding its market presence for TaiTasi and Vidisizumab in China while accelerating the clinical trial processes for pipeline products[33]. Shareholder Structure and Incentives - As of June 30, 2024, the total number of shares outstanding is 544,332,083, comprising 354,750,844 A shares and 189,581,239 H shares[59]. - The company has established partnerships with several limited partnerships for employee incentive plans, holding a total of 102,381,891 A shares among them[59]. - The company has implemented a restricted stock incentive plan for its executives, which includes performance-based conditions[60]. - Major shareholders include RongChang Holding Group LTD. with 53.25% of A shares and 11.47% of H shares, and Wang Xudong holding 54.41% of A shares and 13.31% of H shares[63][64]. Financial Management and Cash Flow - The net cash used in operating activities was RMB 826.3 million for the six months ended June 30, 2024, with cash and cash equivalents decreasing from RMB 726.6 million as of December 31, 2023, to RMB 673.3 million as of June 30, 2024[44]. - The company reported a decrease in cash and cash equivalents of RMB (55,065) thousand for the first half of 2024, compared to a decrease of RMB (968,393) thousand in the same period of 2023[160]. - The net cash flow from financing activities for the first half of 2024 was RMB 1,099,497 thousand, a significant increase from RMB 481,741 thousand in the same period of 2023[160]. Corporate Governance - The company has complied with all applicable corporate governance codes during the reporting period[141]. - The independent auditor, Ernst & Young, reviewed the interim financial information for the six months ending June 30, 2024[143]. - The company has adopted a standard code for securities trading by directors and supervisors, confirming compliance during the reporting period[142].

本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 重要内容提示： 投资者可于 2024 年 9 月 13 日（星期五）16:00 前通过荣昌生物制药（烟 台）股份有限公司（以下简称"公司"）邮箱 rcsw@remegen.com 进行提问。公司 将在说明会上对投资者普遍关注的问题进行回答。 公司已于 2024 年 8 月 17 日发布公司 2024 年半年度报告，为便于广大投资 者更全面深入地了解公司 2024 年半年度经营成果、财务状况，公司参与了由上 海证券交易所主办的 2024 年半年度科创板制药及生物制品专场集体业绩说明会， 此次活动将采用网络文字互动的方式举行，投资者可登录上海证券交易所上证路 演中心（http://roadshow.sseinfo.com/）参与线上互动交流。 一、 说明会类型 本次投资者说明会以网络文字互动形式召开，公司将针对 2024 年半年度的 经营成果及财务指标的具体情况与投资者进行互动交流和沟通，在信息披露允 许的范围内就投资者普遍关注的问题进行回答。 | 证券代码：688331 | 证券简 ...

Investment Rating - The report maintains an "Accumulate" rating for Rongchang Biologics [4][5]. Core Views - The company achieved a revenue of 742 million RMB in H1 2024, representing a year-on-year growth of 75.6%. However, the net profit attributable to shareholders was a loss of 780 million RMB, which increased by 77 million RMB compared to the previous year. The cash and cash equivalents stood at 673 million RMB [5]. - In Q2 2024, the company recorded a revenue of 411 million RMB, up 61.8% year-on-year, with a net profit loss of 432 million RMB, which also increased by 52 million RMB year-on-year. The losses were attributed to multiple pipelines entering Phase III and a significant increase in R&D expenses [5]. - The revenue forecasts for 2024-2026 are maintained at 1.647 billion RMB, 2.504 billion RMB, and 3.319 billion RMB, respectively [5]. Summary by Sections Commercialization and Clinical Progress - The commercialization of Taitasip is accelerating domestically, and the overseas SLE indication is progressing smoothly. The company has established a self-immune sales team of over 800 people and has completed access to over 900 hospitals. With improved operational efficiency and the gradual recovery of hospital access, per capita output is expected to increase, driving continuous growth in performance [5]. - Multiple indications are progressing well: - RA indication was approved in July 2024. - MG domestic Phase III reached the primary clinical endpoint in August, with an NDA submission expected by the end of 2024. - PSS and IgA domestic Phase III trials have completed enrollment. - The overseas SLE Phase III trial has completed the first patient enrollment. - The overseas MG Phase III trial has also completed the first patient enrollment and received FDA's Fast Track Designation [5]. RC48 Development - The RC48 treatment for 1L UC has completed enrollment in Phase III domestically, with ongoing clinical trials overseas. The company has a tumor sales team of over 600 people and has completed access to over 700 hospitals. - RC48+PD1 for 1L UC has completed Phase III enrollment. - According to Pfizer's oncology developer day materials, RC48 monotherapy for 2L UC in the U.S. is in Phase II, with data readout expected in H1 2025. - RC48+PD1 for 1L gastric cancer has shown excellent Phase II IIT data, with Phase III still enrolling. - RC48+PD1 is being advanced for perioperative use and treatment of 2L GC domestically. - RC48 monotherapy for HER2-positive BC with liver metastasis has achieved the primary clinical endpoint in Phase III, with NDA submission expected soon [5]. Catalysts - Potential catalysts include product volume exceeding expectations, innovative drug clinical data surpassing expectations, and financing progress exceeding expectations [5].

Financial Performance - RemeGen Co., Ltd. reported a total revenue of RMB 3.62 billion for the year 2023, representing a year-over-year increase of 25%[1]. - The company reported a total revenue of 990,282 million RMB for the year 2023, with a slight increase from 857,240 million RMB in the previous year, indicating a growth of approximately 15.5%[4]. - The company has set a future revenue guidance of 1,048 million RMB for the upcoming quarter, which represents a projected growth of 5.5% compared to the previous quarter[4]. - RemeGen aims to achieve a revenue growth target of 30% for the upcoming fiscal year, driven by new product launches and market expansion strategies[1]. Research and Development - The company has allocated significant resources towards R&D, with an increase of 15% in R&D expenditure compared to the previous year[1]. - The company is investing in new technology development, with a budget allocation of 44.30 million RMB for R&D in the next fiscal year[4]. Market Expansion and Strategy - The company plans to expand its market presence and is focusing on new product development, particularly in the biopharmaceutical sector[1]. - Market expansion strategies include targeting new geographical regions, aiming for a 20% increase in market share by 2025[4]. - RemeGen is exploring potential mergers and acquisitions to enhance its product portfolio and market reach[1]. - The company is considering potential mergers and acquisitions to enhance its competitive position, with a focus on companies that align with its strategic goals[4]. Customer Engagement and Retention - The company plans to implement a new customer loyalty program, projected to increase customer retention rates by 15%[4]. - The executive team emphasized the importance of adapting to market trends, with a focus on digital transformation to improve customer engagement[4]. - The company reported a user base growth of 20% in its key therapeutic areas, indicating strong market demand for its products[1]. - The user data showed a significant increase, with 345,907 active users reported, compared to 352,202 in the previous period, reflecting a retention challenge[4]. Incentive Plans and Share Grants - The company has granted a total of 850,000 shares under the H-share incentive plan, with a weighted average price of HKD 27.06 per share[2]. - The company granted a total of 2,321,350 shares under the 2022 A-share incentive plan, with a weighted average fair value of RMB 36.36 per share[7]. - The total number of shares granted to the five highest-paid individuals, excluding three executive directors, is 24,200 shares[7]. - The company reported that 79,450 shares were granted to a key executive with a fair value of RMB 49.77 per share[8]. - The shares granted to employees under the incentive plan include 1,253,000 shares with a fair value of RMB 49.77 per share[8]. - The company aims to achieve performance targets based on both group-level and individual-level assessments for the incentive plan[9]. - The incentive plan includes a vesting period from December 28, 2023, to December 28, 2029, for certain granted shares[8]. - The total number of shares that have been granted and vested during the reporting period is 690,000 shares[7]. Performance Assessment - The performance assessment targets for the incentive plan include total revenue (excluding overseas licensing income) and the number of new clinical trials initiated, evaluated annually from 2022 to 2026[9]. - The performance assessment for the 2023 A-share incentive plan includes revenue targets excluding overseas licensing income from Taitasip and the total number of new clinical trials initiated, evaluated annually from 2024 to 2027[10]. - The company has outlined specific performance criteria that must be met for the vesting of restricted shares, including revenue growth and clinical trial initiation[9]. Sustainability and Compliance - The company is committed to maintaining a sustainable growth trajectory while ensuring compliance with regulatory standards in its operations[1]. - The management highlighted a commitment to sustainability initiatives, which are expected to reduce operational costs by 10% over the next three years[4]. Governance - The board of directors includes both executive and non-executive members, ensuring diverse oversight and governance[11].

19 Aug 2024 CMB International Global Markets | Equity Research | Company Update RemeGen (9995 HK) Strong sales performance in 2Q In 2Q24, RemeGen recorded strong product sales, with revenue reaching RMB411mn (+77% YoY), mainly from the product sales of RC18 and RC48, compared to RMB330mn in 1Q24 (+24% QoQ) and RMB254mn in 2Q23 (+62% YoY). The total product sales were RMB729mn in 1H24 (+75% YoY), representing approximately 47% of our previous FY24 estimate, largely in line with our expectations. We are reass ...

Performance Summary [Business Summary](index=1&type=section&id=Business%20Summary) The company achieved significant progress in commercialization, product pipeline, and operations, with strong sales of core products Telitacicept and Disitamab Vedotin driving a **76.5% year-on-year revenue increase**, alongside key clinical trial advancements including FDA Fast Track Designation Revenue Performance for H1 2024 | Metric | H1 2024 (RMB) | H1 2023 (RMB) | YoY Growth | | :--- | :--- | :--- | :--- | | Revenue from Product Sales & R&D Services | 739.7 million | 419.1 million | 76.5% | - Core product Telitacicept (RC18) received FDA Fast Track Designation (FTD) for the treatment of primary Sjögren's Syndrome (pSS)[3](index=3&type=chunk) - Core product Disitamab Vedotin (RC48) achieved its primary endpoint in a Phase III clinical study for HER2-positive advanced breast cancer[3](index=3&type=chunk) - Investigational drug RC88 received FDA FTD for the treatment of platinum-resistant recurrent epithelial ovarian cancer and other indications[4](index=4&type=chunk) [Financial Summary](index=3&type=section&id=Financial%20Summary) For the six months ended June 30, 2024, the Group's revenue reached **RMB 739.7 million** with a gross profit of **RMB 570.4 million**, but a **49.2% increase in R&D expenses to RMB 806.2 million** led to a **11.0% expansion in pre-tax loss to RMB 780.5 million**, with cash and bank balances at **RMB 673.3 million** Key Financial Data for H1 2024 | Financial Metric | Amount (RMB) | YoY Change | | :--- | :--- | :--- | | Revenue | 739.7 million | N/A | | Gross Profit | 570.4 million | N/A | | R&D Expenses | 806.2 million | +49.2% | | Loss Before Tax | 780.5 million | +11.0% | | Loss for the Period | 780.5 million | +11.0% | | Adjusted Net Loss | 743.4 million | +12.7% | | Period-end Bank Balances & Cash | 673.3 million | N/A | Management Discussion and Analysis [Company Overview](index=4&type=section&id=Company%20Overview) The company is a fully integrated biopharmaceutical firm focused on innovative biologics discovery, development, and commercialization in autoimmune, oncology, and ophthalmology, having successfully commercialized two products, Telitacicept and Disitamab Vedotin, and built an integrated platform with over ten drug candidates - The company is positioned as a fully integrated biopharmaceutical company, focusing on three major therapeutic areas: autoimmune diseases, oncology, and ophthalmology[6](index=6&type=chunk) - The company has successfully commercialized two products: Telitacicept (Tai'ai®) and Disitamab Vedotin (Aidexi®), and possesses a product pipeline of over ten drug candidates, with seven in clinical development[6](index=6&type=chunk) [Extensive Product Pipeline](index=5&type=section&id=Extensive%20Product%20Pipeline) As of June 30, 2024, the company's extensive product pipeline spans autoimmune, oncology, and ophthalmology, with core products Telitacicept and Disitamab Vedotin undergoing clinical development for over twenty indications, alongside other candidates like RC88 and RC28 in various clinical stages, demonstrating continuous innovation - The company has over ten drug candidates, with seven in clinical development, targeting more than twenty indications[6](index=6&type=chunk) Key Pipeline Products and Progress | Candidate Drug | Target | Indications (Partial) | Development Stage | | :--- | :--- | :--- | :--- | | Telitacicept (RC18) | BLyS/APRIL | Neuromyelitis Optica, IgG4-Related Disease, etc. | Pivotal/Phase III, Commercialized | | Disitamab Vedotin (RC48) | HER2 | Urothelial Carcinoma, Breast Cancer, Gastric Cancer | Pivotal/Phase III, Commercialized | | RC88 | Mesothelin | Ovarian Cancer, Various Solid Tumors | Phase I/II | | RC28 | VEGF/FGF | Wet Age-related Macular Degeneration, Diabetic Macular Edema | Phase III | [Business Review](index=6&type=section&id=Business%20Review) During the reporting period, the company achieved significant business progress, with core products Telitacicept and Disitamab Vedotin showing positive clinical trial results and regulatory approvals across multiple indications, while ophthalmology drug RC28-E's Phase III study advanced steadily, and other early-stage pipeline products like RC88 demonstrated promising potential [Telitacicept (RC18, Tai'ai®)](index=6&type=section&id=Telitacicept%20(RC18,%20Tai%27ai%C2%AE)) Telitacicept (RC18) demonstrated rapid clinical development progress across multiple autoimmune diseases, with its rheumatoid arthritis (RA) indication approved in China post-period, and key advancements in Phase III trials for primary Sjögren's Syndrome (pSS) and generalized Myasthenia Gravis (gMG), securing FDA Fast Track or Orphan Drug Designations, highlighting its global market potential - In July 2024, Telitacicept was approved for the treatment of rheumatoid arthritis (RA) in China[11](index=11&type=chunk) - For primary Sjögren's Syndrome (pSS), patient enrollment for the Phase III clinical trial in China has been completed, and it received FDA Fast Track Designation (FTD) in March 2024[13](index=13&type=chunk) - For generalized Myasthenia Gravis (gMG), the Phase III clinical trial in China met its primary endpoint, and the first patient was enrolled in the global multi-center Phase III clinical study in the US[14](index=14&type=chunk) [Disitamab Vedotin (RC48, Aidexi®)](index=8&type=section&id=Disitamab%20Vedotin%20(RC48,%20Aidexi%C2%AE)) Disitamab Vedotin (RC48), China's first approved domestic ADC, continues to achieve breakthroughs in treating various HER2-expressing solid tumors, with its Phase III trial for HER2-positive advanced breast cancer with liver metastasis meeting its primary endpoint, and combination studies with PD-1 antibodies for urothelial and gastric cancers showing encouraging efficacy, while global collaboration with Seagen/Pfizer progresses with ongoing international clinical trials - The Phase III clinical trial for HER2-positive advanced breast cancer with liver metastasis achieved positive results, meeting its primary endpoint[20](index=20&type=chunk) - Patient enrollment for the Phase III clinical trial of Disitamab Vedotin combined with a PD-1 antibody as first-line treatment for advanced urothelial carcinoma has been completed[18](index=18&type=chunk) - Global collaboration with Seagen/Pfizer is progressing well, with Seagen conducting a pivotal Phase II clinical trial in the US evaluating Disitamab Vedotin for urothelial carcinoma[21](index=21&type=chunk)[22](index=22&type=chunk) [RC28-E](index=12&type=section&id=RC28-E) RC28-E, a novel VEGF and FGF-targeting fusion protein for ophthalmic diseases, has published positive Ib clinical data for wet Age-related Macular Degeneration (wAMD) in an international journal, demonstrating good safety and efficacy, with its Phase III study initiated in China, and patient recruitment completed for the Phase III trial in Diabetic Macular Edema (DME) - Ib clinical study results for wet Age-related Macular Degeneration (wAMD) were published in an international journal, showing good safety and efficacy, with its Phase III clinical study initiated in China[24](index=24&type=chunk) - Patient recruitment for the Phase III clinical trial of RC28-E for Diabetic Macular Edema (DME) has been completed[25](index=25&type=chunk) [Other Clinical Stage Drug Candidates](index=13&type=section&id=Other%20Clinical%20Stage%20Drug%20Candidates) The company actively advances clinical development for other innovative drugs, with RC88 (mesothelin-targeting ADC) progressing well in Phase II trials for ovarian cancer and other solid tumors, and first patient enrollments achieved for multiple Phase I candidates including RC148 (PD-1/VEGF bispecific antibody), RC198 (IL-15/IL-15Rα fusion protein), and RC248 (DR5-targeting ADC), showcasing a rich early-stage R&D pipeline - RC88 (mesothelin-targeting ADC) is progressing well in its Phase II clinical trial for platinum-resistant recurrent ovarian cancer and other indications[26](index=26&type=chunk) - First patient enrollments have been achieved for Phase I clinical programs including RC148 (PD-1/VEGF bispecific antibody), RC198 (IL-15 fusion protein), and RC248 (DR5-targeting ADC)[27](index=27&type=chunk) [Commercialization Progress](index=15&type=section&id=Commercialization%20Progress) The company established two independent sales teams for autoimmune and oncology products, significantly enhancing market access as core products Telitacicept and Disitamab Vedotin were included in the National Medical Insurance Drug List, with Telitacicept gaining access to over **900 hospitals** and Disitamab Vedotin to over **700 hospitals** by June 30, 2024, demonstrating effective commercialization - The company has established two independent sales teams for autoimmune and oncology fields, responsible for product commercialization[28](index=28&type=chunk) Core Product Hospital Access (As of June 30, 2024) | Product | Number of Hospitals Accessed | | :--- | :--- | | Telitacicept | Over 900 | | Disitamab Vedotin | Over 700 | - Both core products have been included in the National Medical Insurance Drug List, significantly improving product accessibility[28](index=28&type=chunk) [Significant Events After Reporting Period](index=16&type=section&id=Significant%20Events%20After%20Reporting%20Period) Post-reporting period, the company achieved several key milestones, including Telitacicept's rheumatoid arthritis (RA) indication approval in China, its generalized Myasthenia Gravis (gMG) China Phase III trial meeting its primary endpoint, and the first patient enrolled in its global Phase III trial in the US, alongside Disitamab Vedotin's Phase III trial with PD-1 for advanced urothelial carcinoma completing patient enrollment, further solidifying the late-stage pipeline value - In July 2024, Telitacicept was approved for the treatment of rheumatoid arthritis (RA) in China[29](index=29&type=chunk) - In August 2024, Telitacicept's China Phase III clinical trial for generalized Myasthenia Gravis (gMG) met its primary endpoint, and the first patient was enrolled in its global Phase III clinical trial in the US[29](index=29&type=chunk) - In August 2024, patient enrollment for Disitamab Vedotin combined with PD-1 as first-line treatment for advanced urothelial carcinoma Phase III clinical trial was completed[29](index=29&type=chunk) [Future Development](index=16&type=section&id=Future%20Development) The company aims to become a world-class biopharmaceutical leader, continuing to advance the commercialization of Telitacicept and Disitamab Vedotin in China and accelerating other pipeline clinical trials in H2 2024, while internationally focusing on global clinical studies for core products, including multiple Telitacicept Phase III trials in the US, and collaborating with Pfizer/Seagen on Disitamab Vedotin's global development - Domestic Strategy: Continuously advance the commercialization of Telitacicept and Disitamab Vedotin, and accelerate clinical trials for other investigational products[30](index=30&type=chunk) - International Strategy: Accelerate international clinical research for core products, especially Telitacicept's Phase III clinical trials in the US, and collaborate with Pfizer/Seagen to advance the global development of Disitamab Vedotin[30](index=30&type=chunk) Financial Review [Operating Performance Analysis](index=17&type=section&id=Operating%20Performance%20Analysis) In H1 2024, the company's revenue grew **76.5% year-on-year to RMB 739.7 million** due to strong core product sales, but total expenses significantly increased, with R&D expenses rising **49.2% to RMB 806.2 million** and sales and distribution expenses increasing **11.3% to RMB 389.7 million**, alongside higher finance costs, resulting in a **loss for the period expanding from RMB 703.4 million to RMB 780.5 million** Key Income Statement Item Changes for H1 2024 | Item | H1 2024 (RMB) | H1 2023 (RMB) | Reason for Change | | :--- | :--- | :--- | :--- | | Revenue | 739.7 million | 419.1 million | Strong growth in core product sales | | Sales and Distribution Expenses | 389.7 million | 350.2 million | Increased team building and promotional investment | | Administrative Expenses | 155.2 million | 168.6 million | Slight decrease | | R&D Expenses | 806.2 million | 540.5 million | Increased clinical trial expenses (especially overseas) | | Finance Costs | 31.9 million | 6.0 million | Increased interest on bank borrowings and bill discounts | | Loss for the Period | 780.5 million | 703.4 million | R&D and other expenses grew faster than revenue | - The increase in R&D expenses was primarily driven by clinical trial expenses (an increase of **RMB 120.2 million**), raw material expenses (an increase of **RMB 62.2 million**), and employee benefit expenses (an increase of **RMB 33.5 million**)[34](index=34&type=chunk)[35](index=35&type=chunk) [Liquidity and Capital Resources](index=20&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2024, the company's cash and cash equivalents decreased to **RMB 673.3 million** from **RMB 726.6 million** at year-end 2023, primarily used for daily operations, while total interest-bearing bank and other borrowings reached **RMB 2.2745 billion**, and the debt-to-asset ratio rose from **37.8% to 53.7%**, reflecting increased debt financing to support R&D and operations Key Financial Position Indicators | Indicator | June 30, 2024 (RMB) | December 31, 2023 (RMB) | | :--- | :--- | :--- | | Cash and Cash Equivalents | 673.3 million | 726.6 million | | Interest-bearing Bank and Other Borrowings | 2.2745 billion | N/A | | Debt-to-Asset Ratio | 53.7% | 37.8% | - Net cash used in operating activities during the reporting period was **RMB 826.3 million**, primarily funding R&D expenses[40](index=40&type=chunk) Financial Statements [Interim Condensed Consolidated Statement of Profit or Loss](index=23&type=section&id=Interim%20Condensed%20Consolidated%20Statement%20of%20Profit%20or%20Loss) For the six months ended June 30, 2024, the company reported revenue of **RMB 739.7 million**, a **76.5% increase** from **RMB 419.1 million** in the prior year, with gross profit at **RMB 570.4 million**, but high R&D costs (**RMB 806.2 million**) and sales and distribution expenses (**RMB 389.7 million**) led to a pre-tax loss of **RMB 780.5 million**, expanding from **RMB 703.4 million** in the previous period H1 2024 Statement of Profit or Loss Summary | Item (Thousand RMB) | H1 2024 (Unaudited) | H1 2023 (Unaudited) | | :--- | :--- | :--- | | Revenue | 739,656 | 419,073 | | Gross Profit | 570,385 | 316,418 | | R&D Costs | (806,233) | (540,453) | | Loss Before Tax | (780,460) | (703,362) | | Loss for the Period | (780,460) | (703,362) | [Interim Condensed Consolidated Statement of Financial Position](index=25&type=section&id=Interim%20Condensed%20Consolidated%20Statement%20of%20Financial%20Position) As of June 30, 2024, the company's total assets were **RMB 5.7545 billion**, total liabilities **RMB 3.0899 billion**, and net assets **RMB 2.6646 billion**, with total assets slightly decreasing and total liabilities significantly increasing from year-end 2023, primarily due to interest-bearing bank and other borrowings rising from **RMB 1.127 billion to RMB 2.2745 billion**, and net current assets decreasing from **RMB 1.0914 billion to RMB 845.5 million** Statement of Financial Position Summary (As of June 30, 2024) | Item (Thousand RMB) | June 30, 2024 (Unaudited) | December 31, 2023 (Audited) | | :--- | :--- | :--- | | Total Non-current Assets | 3,260,658 | 3,299,310 | | Total Current Assets | 2,493,879 | 2,228,933 | | **Total Assets** | **5,754,537** | **5,528,243** | | Total Current Liabilities | 1,648,428 | 1,137,541 | | Total Non-current Liabilities | 1,441,499 | 953,433 | | **Total Liabilities** | **3,089,927** | **2,090,974** | | **Net Assets** | **2,664,610** | **3,437,269** | Other Information [Corporate Governance and Compliance](index=22&type=section&id=Corporate%20Governance%20and%20Compliance) During the reporting period, the company adopted and complied with all applicable provisions of the Corporate Governance Code, with directors and supervisors confirming adherence to the standard code for securities transactions, and interim financial results reviewed by independent auditor Ernst & Young and confirmed by the audit committee to comply with accounting standards and regulations - The company complied with all applicable provisions of the Corporate Governance Code during the reporting period[46](index=46&type=chunk) - The interim financial information has been reviewed by independent auditor Ernst & Young in accordance with Hong Kong Standard on Review Engagements 2410[47](index=47&type=chunk) [Interim Dividend](index=22&type=section&id=Interim%20Dividend) The Board of Directors does not recommend the payment of an interim dividend for the six months ended June 30, 2024 - The Board of Directors does not recommend the payment of an interim dividend for 2024[48](index=48&type=chunk)

一、"聚焦经营主业，提升核心竞争力"相关措施的实施情况 报告期内，公司持续专注于主营业务的发展，不断提高自身竞争 力，并取得了一定的成效。 1、临床研发方面：公司积极推动泰它西普、维迪西妥单抗、RC88 等分子的临床研究，取得了一系列成果： （1）2024 年 7 月，泰它西普(商品名：泰爱®)新适应症上市申请 获得中国国家药品监督管理局（NMPA）批准，具体为：泰它西普与甲 氨蝶呤联合，用于对甲氨蝶呤疗效不佳的中、重度活动性类风湿关节 炎（RA）成人患者。这是泰它西普在中国获批的第 2 项适应症，其系 统性红斑狼疮适应症（SLE）已于 2021 年 3 月获批国内上市。 （2）2024 年 6 月，维迪西妥单抗(商品名：爱地希®)治疗 HER2 阳性存在肝转移的晚期乳腺癌患者的Ⅲ期临床取得阳性结果，达到主 要研究终点。 （3）2024 年 6 月，2024 年 ASCO 大会公布了 RC88 在铂耐药卵巢 癌中的临床数据，其客观缓解率取得了明显高出标准疗法的惊艳结果。 （4）2024 年 5 月，泰它西普治疗原发性干燥综合征（pSS）的国 内Ⅲ期临床试验已完成全部患者入组。 荣昌生物制药（烟台）股份有限公司 ...

R&D Investment and Product Development - The company is committed to maintaining a significant scale of R&D investment for ongoing product clinical research and global trials, which may lead to increased short-term losses[4]. - The company is actively developing a pipeline of innovative therapies across multiple disease treatment areas[4]. - The company is focused on developing innovative biopharmaceuticals, particularly in the field of antibody drugs, to meet unmet clinical needs[25]. - The company reported a total R&D investment of ¥806,232,656.31, representing a 49.18% increase compared to the previous year[50]. - The company has established three core technology platforms with independent intellectual property rights, enhancing its drug discovery and development capabilities[42]. - The company is actively preparing for clinical trials for several dual/multi-specific antibodies targeting various diseases, including tumors and autoimmune conditions[43]. - The company is focused on increasing research and development investment to enhance its competitive edge in the market[123]. Financial Performance - The company's operating revenue for the first half of the year reached ¥741,756,779.89, a 75.59% increase compared to ¥422,427,546.05 in the same period last year[17]. - The net profit attributable to shareholders was -¥780,459,767.69, compared to -¥703,360,797.19 in the previous year, indicating a continued loss[17]. - The total assets increased by 4.09% to ¥5,754,539,046.77 from ¥5,528,240,704.59 at the end of the previous year[18]. - The basic earnings per share for the first half of the year was -¥1.45, a decrease from -¥1.30 in the same period last year[19]. - The company's R&D investment accounted for 108.69% of operating revenue, down from 127.94% year-on-year, reflecting a 19.25% decrease[19]. - The company reported a weighted average return on equity of -25.62%, a decrease of 10.52 percentage points from -15.10% in the previous year[19]. - The company achieved a revenue of 742 million yuan in the reporting period, representing a 75.59% increase compared to 422 million yuan in the same period last year[61]. Market Position and Strategy - The company is actively pursuing market expansion strategies and new product development to enhance its competitive position in the biopharmaceutical sector[12]. - The company is exploring Taitasib for additional autoimmune diseases, including antiphospholipid syndrome and thrombocytopenia[31]. - The company plans to expand its market presence in Southeast Asia, targeting a 30% increase in market share by the end of 2025[119]. - The company is committed to maintaining a stable dividend policy, with a proposed dividend payout ratio of 40% for the fiscal year[119]. - The company is focused on expanding its commercialization efforts for multiple indications and products, aiming to improve its financial performance and achieve profitability[68]. Clinical Trials and Approvals - The product "Taitasip" (RC18) received full approval in China for the treatment of systemic lupus erythematosus, following conditional approval in November 2023[26]. - The company is involved in clinical trial management through Site Management Organizations (SMOs) to enhance trial quality and compliance with regulations[11]. - The company’s ADC drug, RC48, has received dual breakthrough therapy designation from both the FDA and China's regulatory authority, highlighting its clinical significance[31]. - Taitasib's clinical trial for treating severe myasthenia gravis in China completed patient enrollment in 2023, with results published in a top international journal[27]. - The company plans to submit new drug applications for Taitasib in various indications, reflecting its commitment to expanding its product pipeline[31]. Financial Management and Governance - The board of directors has confirmed the authenticity, accuracy, and completeness of the semi-annual report[5]. - The company maintains transparency in its financial disclosures, with reports available on multiple financial news platforms and its official website[15]. - The company has established a dedicated EHS department to manage pollutant emissions and ensure compliance with environmental regulations[101]. - The company has committed to improving its governance structure to enhance operational efficiency and risk management[125]. - The company will utilize funds from its stock issuance to bolster its main business and capitalize on growth opportunities in the seed industry[123]. Risks and Challenges - The company has outlined various risk factors that may impact its operations and financial status in the report[4]. - The company faces risks related to market competition and potential delays in drug approval processes, which could impact future revenues[70]. - The company reported a net cash flow from operating activities of -820 million yuan, indicating reliance on external financing for working capital[72]. - The company’s financial expenses increased significantly due to higher bank loans and interest costs, with a total of 32 million yuan in financial expenses reported[75]. Shareholder and Equity Information - The company has commitments related to share lock-up periods and restrictions on share transfers, effective from March 31, 2022, until March 31, 2026[110]. - The company will automatically extend the lock-up period by six months if the closing price of A-shares falls below the issue price for a continuous period of twenty trading days[111]. - The company has established a policy to ensure that any share reductions post-lock-up will not be below the IPO price[117]. - The company reported a total of RMB 32,344,000 in related party transactions during the reporting period, with RMB 12,292,070 being the amount incurred[143]. - The company’s registered capital is CNY 544,263,003.00, with a total of 54,426,301 shares issued at a price of CNY 48.00 per share during the IPO[188].

| 证券代码：688331 | 证券简称：荣昌生物 公告编号：2024-040 | | --- | --- | | 港股代码：09995 | 港股简称：榮昌生物 | 荣昌生物制药（烟台）股份有限公司 关于 2024 年度向特定对象发行 A 股股票预案（修订稿） 披露的提示性公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 荣昌生物制药（烟台）股份有限公司（以下简称"公司"）于 2024 年 7 月 24 日召开第二届董事会第十四次会议和第二届监事会第十一次会议，审议通过了《关 于调整公司向特定对象发行股票方案的议案》《关于公司向特定对象发行股票预 案（修订稿）的议案》等相关议案，对公司 2024 年度向特定对象发行 A 股股票预 案进行了修订，相关文件于 2024 年 7 月 25 日在上海证券交易所网站 （www.sse.com.cn）披露，敬请广大投资者注意查阅。 本次向特定对象发行股票预案（修订稿）披露事项不代表审批机关对本次向 特定对象发行股票相关事项的实质性判断、确认或批准，预案所述本次向特定对 象发行 A 股股 ...

证券代码：688331 证券简称：荣昌生物 公告编号：2024-042 港股代码：09995 港股简称：榮昌生物 荣昌生物制药（烟台）股份有限公司 关于 2024 年度向特定对象发行 A 股股票 摊薄即期回报及填补措施与相关主体承诺 （修订稿）的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 荣昌生物制药（烟台）股份有限公司（以下简称"公司""上市公司"或"荣 昌生物"）拟向特定对象发行 A 股股票（以下简称"本次向特定对象发行股票" 或"本次发行"）。根据《国务院办公厅关于进一步加强资本市场中小投资者合法 权益保护工作的意见》（国办发[2013]110 号）《国务院关于进一步促进资本市场 健康发展的若干意见》（国发[2014]17 号）和《关于首发及再融资、重大资产重 组摊薄即期回报有关事项的指导意见》（证监会公告[2015]31 号）等法律、法规、 规章及其他规范性文件的要求，为保障中小投资者利益，公司就本次向特定对象 发行股票事项对即期回报摊薄的影响进行了分析，结合实际情况提出了具体的填 补回报措施，且相关主体对填 ...